A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

PHASE3CompletedINTERVENTIONAL
Enrollment

687

Participants

Timeline

Start Date

November 9, 2020

Primary Completion Date

July 13, 2022

Study Completion Date

April 17, 2023

Conditions
HIV Infections
Interventions
DRUG

Cabotegravir Tablets

CAB tablets were available as film coated tablets for oral administration.

DRUG

Cabotegravir Injectable Suspension (CAB LA)

CAB LA was available as sterile suspension for injection in GSK1265744 for administration as IM injection.

DRUG

Rilpivirine Tablets

RPV was administered as tablets for oral administration.

DRUG

Rilpivirine Injectable Suspension (RPV LA)

RPV LA was available as a sterile suspension of RPV to be administered as an IM injection.

DRUG

BIKTARVY Tablets (BIK)

BIK was a three-drug fixed dose combination product BIC, FTC, and TAF for oral administration.

Trial Locations (117)

8

GSK Investigational Site, Dublin

1011

GSK Investigational Site, Lausanne

2010

GSK Investigational Site, Darlinghurst

GSK Investigational Site, Darlinghurst, Sydney

GSK Investigational Site, Sydney

3000

GSK Investigational Site, Leuven

3010

GSK Investigational Site, Bern

3181

GSK Investigational Site, Prahran

3500

GSK Investigational Site, Hasselt

4000

GSK Investigational Site, Liège

4021

GSK Investigational Site, Linz

6042

GSK Investigational Site, Lodelinsart

8091

GSK Investigational Site, Zurich

10117

GSK Investigational Site, Berlin

10149

GSK Investigational Site, Turin

10439

GSK Investigational Site, Berlin

10467

GSK Investigational Site, The Bronx

10787

GSK Investigational Site, Berlin

13210

GSK Investigational Site, Syracuse

19107

GSK Investigational Site, Philadelphia

20127

GSK Investigational Site, Milan

20157

GSK Investigational Site, Milan

20246

GSK Investigational Site, Hamburg

21005

GSK Investigational Site, Huelva

21052

GSK Investigational Site, Busto Arsizio (VA)

21201

GSK Investigational Site, Baltimore

24127

GSK Investigational Site, Bergamo

25123

GSK Investigational Site, Brescia

27100

GSK Investigational Site, Pavia

27710

GSK Investigational Site, Durham

27834

GSK Investigational Site, Greenville

28006

GSK Investigational Site, Madrid

28040

GSK Investigational Site, Madrid

28078

GSK Investigational Site, Huntersville

28222

GSK Investigational Site, Majadahonda( Madrid

28401

GSK Investigational Site, Wilmington

28805

GSK Investigational Site, Alcalá de Henares

30033

GSK Investigational Site, Atlanta

32503

GSK Investigational Site, Pensacola

33076

GSK Investigational Site, Bordeaux

33133

GSK Investigational Site, Miami

33407

GSK Investigational Site, West Palm Beach

33602

GSK Investigational Site, Tampa

34982

GSK Investigational Site, Ft. Pierce

41014

GSK Investigational Site, Seville

41124

GSK Investigational Site, Modena

43614

GSK Investigational Site, Toledo

44093

GSK Investigational Site, Nantes

44787

GSK Investigational Site, Bochum

46010

GSK Investigational Site, Valencia

46015

GSK Investigational Site, Valencia

46026

GSK Investigational Site, Valencia

48075

GSK Investigational Site, Southfield

50668

GSK Investigational Site, Cologne

50674

GSK Investigational Site, Cologne

52062

GSK Investigational Site, Aachen

53127

GSK Investigational Site, Bonn

53226

GSK Investigational Site, Milwaukee

59208

GSK Investigational Site, Tourcoing

60612

GSK Investigational Site, Chicago

60613

GSK Investigational Site, Chicago

63000

GSK Investigational Site, Clermont-Ferrand

66160

GSK Investigational Site, Kansas City

67214

GSK Investigational Site, Wichita

70112

GSK Investigational Site, New Orleans

70117

GSK Investigational Site, New Orleans

75208

GSK Investigational Site, Dallas

75246

GSK Investigational Site, Dallas

77098

GSK Investigational Site, Houston

77401

GSK Investigational Site, Bellaire

80204

GSK Investigational Site, Denver

80336

GSK Investigational Site, Munich

90027

GSK Investigational Site, Los Angeles

90033

GSK Investigational Site, Los Angeles

90036

GSK Investigational Site, Los Angeles

90211

GSK Investigational Site, Beverly Hills

92262

GSK Investigational Site, Palm Springs

93009

GSK Investigational Site, Bobigny

93301

GSK Investigational Site, Bakersfield

94010

GSK Investigational Site, Créteil

94102

GSK Investigational Site, San Francisco

94275

GSK Investigational Site, Le Kremlin-Bicêtre

98104

GSK Investigational Site, Seattle

06510

GSK Investigational Site, New Haven

02043

GSK Investigational Site, Boston

02115

GSK Investigational Site, Boston

07103

GSK Investigational Site, Newark

27401-1209

GSK Investigational Site, Greensboro

A-6020

GSK Investigational Site, Innsbruck

A-1090

GSK Investigational Site, Vienna

R3A 1R9

GSK Investigational Site, Winnipeg

K1H 8L6

GSK Investigational Site, Ottawa

M5B 1W8

GSK Investigational Site, Toronto

M5G 1K2

GSK Investigational Site, Toronto

M5G 2N2

GSK Investigational Site, Toronto

H2L 4E9

GSK Investigational Site, Montreal

H2L 4P9

GSK Investigational Site, Montreal

H3A 1T1

GSK Investigational Site, Montreal

H4A 3J1

GSK Investigational Site, Montreal

S4P 0W5

GSK Investigational Site, Regina

06202

GSK Investigational Site, Nice

D09 V2N0

GSK Investigational Site, Dublin

00149

GSK Investigational Site, Rome

460-0001

GSK Investigational Site, Aichi

540-0006

GSK Investigational Site, Osaka

108-8639

GSK Investigational Site, Tokyo

162-8655

GSK Investigational Site, Tokyo

1091 HA

GSK Investigational Site, Amsterdam

1105 AZ

GSK Investigational Site, Amsterdam

09006

GSK Investigational Site, Burgos

08830

GSK Investigational Site, Sant Boi de Llobregat

CH-1205

GSK Investigational Site, Geneva

L7 8XP

GSK Investigational Site, Liverpool

G12 OYN

GSK Investigational Site, Glasgow

SE1 9RT

GSK Investigational Site, London

SW10 9TH

GSK Investigational Site, London

M8 5RB

GSK Investigational Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen, LP

INDUSTRY

lead

ViiV Healthcare

INDUSTRY